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Coordinates and manages clinical trials/protocols in the Department of Medicine, ensuring adherence to protocol requirements and regulatory guidelines. Manages the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data. As the primary resource for the protocols, the Clinical Research Specialist will act as a liaison between the investigators, primary care providers, the Institutional Review Board (IRB), the sponsor, study subjects and study team. Along with the investigator, the CRS will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the CRS will assist the Primary Investigator with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files. In additionally the CRS will be responsible for patient education, case management with follow up phone calls, tracking of costs per case and clinical outcomes.

MINIMUM QUALIFICATIONS :

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Bachelor of Science Nursing and License to practice professional nursing in the state of WV OR an advanced degree (i.e. MA, MD, PhD) in a scientific, healthcare, or other related field.

2. Obtain certification in Basic Life Support within 30 days of hire date.

3. Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date.

EXPERIENCE:

1. Three (3) years clinical experience.

PREFERRED QUALIFICATIONS :

EXPERIENCE:

1. Two (2) years research experience.

CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an all-inclusive list of all responsibilities and duties. Other duties may be assigned.

1. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and provides administrative and regulatory management of protocols and clinical trials ensuring compliance with WVU IRB, GCP guidelines and code of federal regulations.

2. Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.

3. Develops a mechanism for subject recruitment and ongoing communications with the primary care physician and nursing staff and serves as a liaison between the WVU IRB, PI and Sponsor or Sponsor’s representative, as appropriate.

4. Reports Serious Adverse Events, FDA Safety Reports, deviations from protocol, and compassionate use of protocol to WVU IRB and Sponsor.

5. Prepares Annual Protocol Reviews and Study Summaries for submission to WVU IRB. Notifies the IRB of study completion, per IRB procedure.

6. Prepares and reviews clinical trial budgets. Reviews and submits clinical Trial Agreements (including clinical trial budgets) to the WVU Office of Sponsored Programs.

7. Maintains confidential files of regulatory documents including informed consent and assent documents.

8. Coordinates Protocol Review Committee Meetings, and attends other study related meetings as necessary, to ensure peer review of all protocols under consideration for IRB submission.

9. Trains support staff (e.g. data entry, clerical staff) as necessary.

10. Clinical coordination of protocols and clinical trials.

11. Reviews with the PI the inclusion/exclusion criteria, overall structure, and requirements of each protocol and the protocols summary sheet and informed consent form for accuracy and clarity. Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled.

12. Schedules subjects for follow-up visits and coordinates required testing and services with other departments (laboratory, pharmacy, etc.). Performs patient follow up phone calls.

13. Assesses subject response to therapy and evaluates for adverse events. Assesses and documents subject compliance with medications and visits.

14. Assures appropriate specimen collections. Reviews laboratory data and communicates abnormal values to the primary care provider and investigator.

15. Communicates regulatory with the PI about study-related issues.

16. Assesses and records all adverse experiences as outlined in protocol and reports all serious adverse experiences to the PI, sponsor’s monitor, primary care physician, and IRB as outlined in the protocol.

17. Provides quality assurance for the clinical protocols and investigations. Ensures the randomization procedure is followed as per protocol guidelines.

18. Reviews and documents all protocol deviations, missing or lost data and communicates all protocol deviations to the IRB, Principal Investigator and other departmental representatives as applicable.

19. Assesses validity of research data. Utilizes computer software to provide statistical analysis and summary of the research data. Applies in-depth knowledge of research to analyze the data results from clinical protocols and investigations.

20. Ensures timely and accurate Case Review Forms (CRF) completion for each study subject. Maintains source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports. Corrects and edits CRFs as appropriate. Provides auditors with completed CRFs, medical records, lab data and other source documents for review. Corrects and edits CRFs as appropriate.

21. Explores and evaluates opportunities for federal, state, private and institutional funding and external presentations.

22. Assists in the writing and submission of a grant application. Coordinates activities associated with receiving funding.

23. Participates in writing and submitting manuscripts, abstracts and posters. Conducts literature searches.

24. Coordinates with appropriate MD care management of research patients undergoing treatment.

25. Tracks cost per case, identifies opportunities for improvement.

26. Monitors clinical outcomes as assigned.

PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. May require travel to outreach sites of service to see study patients.

WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Typical clinical and administrative office environment.

• CA

Additional Job Description:

Scheduled Weekly Hours:

40

Shift:

Exempt/Non-Exempt:

United States of America (Exempt)

Company:

WVUH West Virginia University Hospitals

Cost Center:

55 WVUH Nursing Cancer and Infusion Center

Address:

1 Medical Park Drive

Wheeling

West Virginia